Efficacy and Safety of Asenapine With Placebo and Olanzapine (41021)(P05933)

NCT ID: NCT00156117

Last Updated: 2024-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-12
• Study Completion Date: 2006-05-30

Brief Summary

Schizophrenia is a brain disease. The primary features of schizophrenia are characterized by Positive symptoms (symptoms that should not be there, inability to think clearly, to distinguish reality from fantasy i.e., hearing voices) and Negative symptoms (a reduction or absence of normal behaviors or emotions, i.e., unable to manage emotions, make decisions and relate to others). Other symptoms include reduced ability to recall and learn new information, difficulty with problem solving, or maintaining productive employment. The symptoms of schizophrenia may be due to an imbalance in chemicals in the brain, primarily dopamine and serotonin, which enables brain cells to communicate with each other.

Asenapine is an investigational drug that may help to correct the imbalance in dopamine and serotonin. This is a 6 week study to test the efficacy and safety of asenapine and a comparator agent (olanzapine) in the treatment of patients with schizophrenia. Patients that complete this trial will have the option of continuing in an additional one year extension trial.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

asenapine 5 mg BID and 10 mg BID

Group Type: EXPERIMENTAL

asenapine

Intervention Type: DRUG

5 mg BID or 10mg BID

2

Placebo against olanzapine and asenapine

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

3

olanzapine 15 mgQD

Group Type: ACTIVE_COMPARATOR

olanzapine

Intervention Type: DRUG

olanzapine 15 mg QD

Interventions

asenapine

5 mg BID or 10mg BID

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

olanzapine

olanzapine 15 mg QD

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Currently suffering from an acute exacerbation of schizophrenia. Caregiver required.

Exclusion Criteria

• Have an uncontrolled, unstable medical condition. Have any other psychiatric disorder other than schizophrenia as a primary diagnosis.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Organon and Co

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

Szegedi A, Verweij P, van Duijnhoven W, Mackle M, Cazorla P, Fennema H. Meta-analyses of the efficacy of asenapine for acute schizophrenia: comparisons with placebo and other antipsychotics. J Clin Psychiatry. 2012 Dec;73(12):1533-40. doi: 10.4088/JCP.11r07596.

Reference Type: RESULT

PMID: 23290326 (View on PubMed)

Castle DJ, Slott Jensen JK. Management of depressive symptoms in schizophrenia. Clin Schizophr Relat Psychoses. 2015 Apr;9(1):13-20. doi: 10.3371/CSRP.CAJE.103114.

Reference Type: DERIVED

PMID: 25367164 (View on PubMed)

Other Identifiers

Hera

Identifier Type: -

Identifier Source: secondary_id

41021

Identifier Type: -

Identifier Source: secondary_id

P05933

Identifier Type: -

Identifier Source: org_study_id